USFDA SPL and Health Canada SPM
SPL/SPM Services
Structured Product Labeling (SPL) for USFDA ANDA, NDA, BLA, Cosmetics and Facility RegistrationSPL/SPM Services : Structured Product Labeling (SPL) and Structured Product Monograph (SPM) is an XML-based markup standard approved by Health Level Seven (HL7) and adopted by the USFDA and Health Canada for the exchange of product and facility information. The USFDA mandates SPL in XML format for the submission of labeling sections, along with PDF and Word documents, in ANDA, NDA, and BLA applications. Health Canada has also started accepting SPM for ANDS, NDS, sANDS, and sNDS.
Our professional team boasts unparalleled expertise in offering SPL/SPM conversion services across various product type; Rx & OTC drug listing, API/Bulk Ingredient Listing, Establishment Registration, NDC/NHRIC Labeler Code, GDUFA Self-Identification and Cosmetic MoCRA Registration. With a proven track record of serving over 100 satisfied firms by using our secure and validated cloud-based platform, NextGen SPL. Our team at Masuu Regulatory Labeling specializes in converting and validating SPL/SPM files (XML) that comply with FDA and Health Canada standards. Using package inserts and medication guides, we create clean copies and comparison documents for conversion. We offer SPL submission packages for various types of submissions to the USFDA, ensuring they meet client needs for the Electronic Drug Registration and Listing Systems (eDRLS):- NDC Labeler Code Request
- NDC Labeler Code Inactivation
- Establishment Registration
- Establishment De-Registration
- GDUFA Identification (CDER and CBER)
- No Change Notification
- Out of Business Notification
- REMS Labeling
- Drug Labeling (Prescription, OTC, and Compounded)
- Core Labeling
- Compounded Drug Reporting
- Home Use Medical Device Labeling
- Lot Distribution Data
- Medical Food Labeling
- Medicated Animal Feed Establishment
- Bulk Ingredient Labeling
- Cosmetic Labeling
- Homeopathic Labeling
- Medical Device Labeling
- Dietary Supplement Labeling
- Plasma Derivative Labeling
- Vaccine Labeling
- Cellular Therapy Labeling
- Blanket No Change Certification of Product Listing
- Accuracy and Cost-effectiveness: We provide precise and affordable services tailored to various SPL types, including ER, NDC, GUDFA, RX, OTC, and Cosmetic.
- FDA and Health Canada Compliance: Our SPL/SPM files are fully compliant and validated according to FDA specifications.
- Pre-defined Templates: We use in-house, pre-defined templates for a wide range of SPLs.
- Lifecycle Management: We handle the complete lifecycle management of SPLs, including version and set ID management.
- Zero-error Validation: We ensure SPL validation with zero errors, adhering to FDA specifications.
- Expert Review: Our Labeling SMEs conduct thorough cross-reviews of COL (Content of Labeling), PDP (Principal Display Panel), and DLD (Drug Listing Data Element) sections of SPLs, including Set ID, version number, DUNS number, NDC, registrant, labeler, and establishment information.
Frequently Asked Questions
Structured Product Labeling (SPL) is an XML-based format used to electronically submit product labeling and facility information to the USFDA. It enables standardized data exchange and supports regulatory review, drug listing, and establishment registration. SPL is required for applicable submissions, including ANDA, NDA, and BLA applications.
SPL is the structured XML format adopted by the USFDA for product labeling and registration information, while SPM refers to Health Canada’s Structured Product Monograph. Both support standardized electronic regulatory submissions, but their technical specifications, content requirements, and submission processes differ. Masuu Global provides conversion and validation support for both formats.
SPL conversion services cover a wide range of products, including prescription drugs, OTC medicines, active pharmaceutical ingredients, compounded drugs, vaccines, medical devices, cosmetics, dietary supplements, and plasma derivatives. The applicable requirements depend on the product category and submission type. Masuu Global supports companies in preparing the relevant XML files for regulatory submissions.
Yes, Masuu Global provides support for FDA establishment registration, deregistration, and NDC labeler code requests. Our team assists with preparing and validating the required SPL files while ensuring that establishment and labeler information is accurate. We also support related notifications and drug listing activities.
The required information depends on the submission type but generally includes approved labeling documents, product details, establishment information, NDC or other applicable identifiers, and relevant registration data. Our team reviews the source documents, identifies missing information, and prepares the structured XML file according to the applicable regulatory specifications.
We use predefined templates, structured conversion processes, and validation checks to ensure that SPL and SPM files align with applicable FDA and Health Canada specifications. Our labeling specialists review critical data elements, including Set ID, version number, NDC, establishment details, and labeling content, to identify inconsistencies before submission.
Yes, existing SPL files can be revised to reflect changes in product labeling, registration details, or other regulatory information. Masuu Global manages version control, Set ID updates, and lifecycle changes to maintain consistency across submissions. This helps companies keep their regulatory records accurate and up to date.
Yes, our services extend beyond pharmaceutical products to include applicable cosmetic and medical device labeling and registration requirements. We support SPL preparation for relevant product categories, including cosmetic MoCRA registration and home-use medical device labeling. Our team considers the specific regulatory requirements associated with each submission.
Common challenges include XML formatting errors, incomplete product information, incorrect identifiers, inconsistent labeling content, and version control issues. These errors may result in submission rejections or additional regulatory work. Professional conversion and validation services help identify such issues early and improve submission accuracy.
Masuu Global combines regulatory labeling expertise, predefined templates, and validated cloud-based processes to support accurate and efficient SPL/SPM conversion. Our services cover initial preparation, expert review, validation, submission support, and lifecycle management. We help pharmaceutical and healthcare companies maintain compliant regulatory records across applicable product categories and markets.